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  • 1.  Amazon's 6 - Page Narrative

    This message was posted by a user wishing to remain anonymous
    Posted 27-Dec-2021 10:44
    This message was posted by a user wishing to remain anonymous

    Has anyone used Amazon's 6 - Page Narrative for communicating medical device regulation to Top Management and/or the organization as a whole? Any examples?

    Why Jeff Bezos makes Amazon execs read 6-page memos at the start of each meeting

    This is the route I am thinking of using as I onboard my organization to the world of medical device regs.


  • 2.  RE: Amazon's 6 - Page Narrative

    This message was posted by a user wishing to remain anonymous
    Posted 28-Dec-2021 09:06
    This message was posted by a user wishing to remain anonymous

    Hi 
        Though the Intent to write a 6-Page Narrative are clear the outcome in a Medical new Product development or for the outset for conformance to a standard needs to be communicated to multiple partners.
             
    Amazon being a Customer facing and inventory intensive needs to plan for specific scenarios that may not have a direct binding on Medical Standards, however the process side will be useful to communicate and align partners
        1) Need of Product ->  Notifying Bodies and Declaration of Conformity may be aligned to market a product
        2) Regulatory, sustainability and Risk Compliance -> Applicable Standards and Sustainability goals may be mapped to list company Sustainability alignment
        3) Marketing Strategy and Target Segmentation may need to align with Data Privacy, HIPAA or GDPR regulations
         4) Product Marketing and Feedback would be better aligned to PMS/Post market Surveillance and Yearly failure assessments
        5) Profit and Motive - Debatable area
         6) People and Process - QA/RA community has done yeoman  service and is a guidepost for community to continue with disparate -yet to be harmonised - and multitude of standards

    I guess the existing framework for a QA/RA person would be to ensure that the legal tenets of Medical regulation regarding Patient Safety,  Privacy along with the Product Safety, Sustainability would align to a 6 page memo, except for the motive :-)    

    Wishing you a Happy New Year!.

    Original Message


  • 3.  RE: Amazon's 6 - Page Narrative

    This message was posted by a user wishing to remain anonymous
    Posted 28-Dec-2021 09:06
    This message was posted by a user wishing to remain anonymous

    Woah!  No - but love the idea!  ...

    "If we don't, the executives, like high school kids, will try to bluff their way through a meeting," says the CEO at a recent Forum on Leadership. "[The memo is] supposed to create the context for what will then be a good discussion."


    Original Message


  • 4.  RE: Amazon's 6 - Page Narrative

    Posted 29-Dec-2021 03:47
    Interesting read, thanks for sharing.  I would love to see a Management Review meeting of the 120 slides in a 6 page narrative memo :).

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 5.  RE: Amazon's 6 - Page Narrative

    This message was posted by a user wishing to remain anonymous
    Posted 30-Dec-2021 15:24
    This message was posted by a user wishing to remain anonymous

    I heard of this when I learned about Nancy Duarte's SlideDoc concept - slides with more text that are visual and make a point. I later her took her class on it. If you create a SlideDoc, that is really well written, I think this would work. However, you'll spend a lot of time making a great SlideDoc that gets to the point.
    Original Message


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